ALPHAPRESS 25 hydralazine hydrochloride 25mg tablet bottle

Negara: Australia

Bahasa: Inggris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

hydralazine hydrochloride, Quantity: 25 mg

Tersedia dari:

Alphapharm Pty Ltd

Bentuk farmasi:

Tablet, uncoated

Komposisi:

Excipient Ingredients: microcrystalline cellulose; pregelatinised maize starch; colloidal anhydrous silica; magnesium stearate; sodium starch glycollate; disodium edetate; purified talc

Rute administrasi :

Oral

Unit dalam paket:

60 tablets, 100 tablets, 90 tablets

Kelas:

Medicine Registered

Jenis Resep:

(S4) Prescription Only Medicine

Indikasi Terapi:

This product accepted for registration as 'currently supplied' at the time of commencement of the Act. Variation to Pregnancy Statement in Product Information were approved as specified in the letter of 13 August 1992 from Dr Bijoy Varma. Indicated for the treatment of drug resistant, moderate to severe, hypertension. This drug is not a first line antihypertensive drug and is better used in combination with other therapy such as a sympatholytic agent and a diuretic. INDICATIONS AS AT 28 NOVEMBER 2001 : Hypertension (drug resistant, moderate to severe): as supplementary medication for use together with other antihypertensives such as "beta"-blockers and diuretics; the complementary mechanisms of action of such combined therapy enable the drugs to exert their antihypertensive effects at low doses; in addition, unwanted accompanying effects of the individual substances are either partially offset or even cancelled out.

Ringkasan produk:

Visual Identification: 8 mm cream, flat bevelled edged tablet with a score mark on one side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Status otorisasi:

Registered

Tanggal Otorisasi:

1991-09-20

Selebaran informasi

ALPHAPRESS
_hydralazine hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ALPHAPRESS. It
does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking
ALPHAPRESS against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ALPHAPRESS IS
USED FOR
ALPHAPRESS is used to lower high
blood pressure, also known as
hypertension. It is normally used
together with other medicines for
high blood pressure.
This medicine works by widening the
blood vessels so that blood passes
through them more easily. This helps
to lower blood pressure.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
There is not enough information to
recommend the use of this medicine
in children.
This medicine is available only with
a doctor's prescription.
There is no evidence that this
medicine is addictive.
BEFORE YOU TAKE
ALPHAPRESS
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE ALPHAPRESS IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
hydralazine hydrochloride
•
any of the ingredients listed at the
end of this leaflet
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin
DO NOT TAKE ALPHAPRESS IF YOU
HAVE:
•
systemic lupus erythematosus
(SLE)
•
certain heart conditions such as
heart failure, narrowing of the
valves in the heart or swelling
around the heart
•
a very fast, irregular or pounding
heart beat
•
a condition called dissecting
aortic aneurysm where there is
swelling and weakening of a large
blood vessel
•
thyro

Karakteristik produk

AUSTRALIAN PRODUCT INFORMATION
ALPHAPRESS
_hydralazine hydrochloride film coated tablet _
1
NAME OF THE MEDICINE
Hydralazine hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ALPHAPRESS tablet contains either 25 mg and 50 mg of hydralazine
hydrochloride as the active
ingredient.
Excipients of known effect: lactose monohydrate (50 mg only) and
traces of sulfites.
For the full list of excipients, see section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
ALPHAPRESS 25: flat bevelled edged cream tablet with score mark on one
side.
ALPHAPRESS 50: pink film coated normal convex tablet marked HE 50 on
one side, G on reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
HYPERTENSION (DRUG RESISTANT, MODERATE TO SEVERE)
As
_supplementary medication_
for use together with other antihypertensives such as beta-blockers
and
diuretics; the complementary mechanisms of action of such combined
therapy enable the drugs to exert their
antihypertensive effects at low doses; in addition, unwanted
accompanying effects of the individual substances
are either partially offset or even cancelled out.
4.2
DOSE AND METHOD OF ADMINISTRATION
The dosage must always be adjusted to the individual requirements of
the patient and the following
recommendations adhered to.
ADULTS
Treatment should begin with low doses of ALPHAPRESS, which, depending
on the patient's response, should
be increased stepwise in order to achieve an optimal therapeutic
effect and to avoid unwanted effects as far as
possible.
Give ALPHAPRESS in a twice daily regimen; the usual starting dosage of
25 mg twice daily is generally
sufficient. This dosage can be increased as required within the
effective maintenance dosage range of 50 to
200 mg daily. However, the dose should not be increased above 100 mg
daily without determining the
acetylator phenotype (see section 4.4 Special Warnings and Precautions
for Use).
CHILDREN
Safety and efficacy of hydralazine have not been established in
children.
4.3
CONTRAINDICATIONS
•
Known hypersensitivity to hydralazine or